To hear about similar clinical trials, please enter your email below
Trial Title:
SBRT Combined With Fruquintinib Plus PD-1/CTLA-4 Antibody for Third-line Treatment in mCRC
NCT ID:
NCT05747716
Condition:
Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SBRT, Fruquintinib, Cadonilimab
Description:
Radiation: Stereotactic body radiationtherapy (SBRT) for metastatic sites (less than 5)
Fruquintinib: 5mg, po, everyday; Cadonilimab: 10mg/kg, iv, q3w
Arm group label:
SBRT, Fruquintinib, Cadonilimab
Summary:
The study is a phase II clinical study. The purpose of the study is to evaluate the
efficacy and safety of SBRT combined with Fruquintinib Plus PD-1/CTLA-4 Antibody for
Third-line Treatment in mCRC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients must have biopsy proven unresectable MCRC.
2. Patients must have received first-line and second-line chemotherapy, and approved a
progressive disease.
3. Age ≥ 18 years
4. Patients must have measurable disease at baseline.
5. Patients can have up to only 5 discrete active extracranial lesions (≤3 in the liver
and ≤3 in the lung) identified by position-emission tomography (PET) scan and also
seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the
initiation of radiotherapy.
6. Patients who previously received radiotherapy to the primary site will be ineligible
if there is CT evidence of disease progression within the past 3 months.
7. Patients must have a Karnofsky Performance Scores (KPS) >60 8. Aspartate
aminotransferase, alanine aminotransferase & Alkaline phosphates must be ≤ 2.5 times
the upper limit of normal (ULN). Total bilirubin must be within the limit of normal.
9. Patients should have adequate bone marrow function as defined by peripheral
granulocyte count of ≥1500/mm3. 10. Patients should have adequate renal function
(serum creatinine ≤1.5 times the ULN). 11. Females of childbearing potential should
have a negative pregnancy test. 12. Patients who would be receiving radiation for
lung lesions who are known or suspected by the treating radiation oncologist to have
compromised lung function must have a documented forced expiratory volume in 1
second (FEV1) ≥ 1 litre.
13. Patients must provide verbal and written informed consent to participate in the
study.
14. Total bilirubin: within normal institutional limits
Exclusion Criteria:
1. Patients with either untreated brain metastases or brain metastases treated within
the past three months are ineligible
2. Patients with serious, uncontrolled, concurrent infection(s).
3. Significant weight loss (>10%) in the prior 3 months.
4. Treatment for other carcinomas within the last five years, except cured non-melanoma
skin and treated in-situ cancers.
5. Patients with more than 5 discrete metastatic lesions.
6. Participation in any investigational drug study within 4 weeks preceding the start
of study treatment.
7. Unwillingness to participate or inability to comply with the protocol for the
duration of the study.
8. Patients who are pregnant. Patients with reproductive capability will need to use
adequate contraception during the time of participation in the study
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Start date:
February 28, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05747716
